Events

Retiro De Equipo (Recall) de Red Head 2

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Miami Fat Supply, Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    74156
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1957-2016
  • Fecha de inicio del evento
    2016-04-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-12-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146527
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, suction, lipoplasty - Product Code MUU
  • Causa
    During an fda inspection it was found that the products are marketed without a cleared 510k, nor is approved for multiple use.
  • Acción
    Customers were sent an Urgent: Medical Device Recall/Correction letter, dated 04/19/2016, on 04/21/2016 that served as a notification of the Red Head 2 voluntary recall. Customers were informed that there were previous complaints of compromised product integrity and performance following sterilization. Lids are subject to fracture and fail after steam sterilization. Customers were advised to destroy used product and to ship unused product back to the manufacturer. Customers were to return an acknowledgement form to confirm their notification of the voluntary recall.

Device

Red Head 2
  • Modelo / Serial
    Lots 1165 and 1271.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US, including the states of AL, AZ, CA, CO, FL, GA, IL, MD, MI, MO, NM, NY, OH, TX, UT, and VA; and, the country of Dominican Republic.
  • Descripción del producto
    The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile. || Intended for use in aspirating subcutaneous fatty tissue in patients desiring aesthetic body contouring and autologous fat collection.
  • Manufacturer
    Miami Fat Supply, Inc

Manufacturer

Miami Fat Supply, Inc
  • Dirección del fabricante
    Miami Fat Supply, Inc, 1510 Max Hooks Rd Ste F, Groveland FL 34736-8032
  • Empresa matriz del fabricante (2017)
    Miami Fat Supply
  • Source
    USFDA